Joint Disease
Conditions
Brief summary
Single center, prospective follow-up of previously implanted subjects
Detailed description
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Interventions
DEVICEPROFEMUR® Z Revision Femoral Stem
Total Hip Total Hip Arthroscopy
Sponsors
MicroPort Orthopedics Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone). 2. Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA. 3. Subject is willing and able to complete required study visits or assessments. 4. Plans to be available through the 10 year postoperative follow-up visit. Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1. the PROFEMUR Z Revision Femoral Stem was implanted in both, 2. all other aspects of the Inclusion/
Exclusion criteria
are satisfied, 3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4. the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of ProFemur Z Stem out to 10 years | 10 years. | Kaplan-Meier survivorship at specific intervals out to 10 years follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision rate of the Profemur Z stem out to 10 years | 2-5 years, 5-7 years, and 10 years. | Cummulative revision rate at early (2-5yrs), midterm (5-7 year) and long-term (10 year) follow up. |
| to characterize total functional scores for subjects, as assessed by Oxford Hip Scores | 2-5 years, 5-7 years, and 10 years. | The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'. |
Other
| Measure | Time frame | Description |
|---|---|---|
| to characterize total functional scores for subjects, as assessed by EQ-5D-3L scores. | 2-5 years, 5-7 years, and 10 years. | EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems. |
Countries
Poland
Outcome results
None listed